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To identify criteria used by French health authorities to assess the clinical added value (ASMR) of drugs seeking reimbursement.We conducted a systematic review of the opinions of the transparency committee (TC) of the French national authority for health (HAS) between March, 2014 and October, 2016 in ten therapeutic areas. TC opinions content was coded and analysed using descriptive statistics and logistic models.The database comprised 160 opinion texts, which included ASMR assessments using a 5 level scale (1=highest ASMR 5=no ASMR). Main elements that were linked with ASMR 1,2,3,4 as compared to ASMR 5 were appraisal of the medical need, population size (5000 patients), and clinical relevance of the evaluated results. The factors associated with ASMR 4 as compared to ASMR 1-3 were the safety profile and clinical relevance of the results. However, the factors associated with ASMR level varied according to the therapeutic area considered.The assessment of the drug ASMR conducted by the French transparency commission of the HAS appears to be at least in part determined by criteria (medical need, population size) which reflect the burden of the disease but not reflect the ASMR of the medicine assessed. Other criteria used for the assessment of ASMR are not clearly defined and depend on the therapeutic domain. The lack of sufficient clarity and consistency in assessment of ASMR complicate the decision making process for drug development. Moreover, this situation can be a barrier for a harmonized process of ASMR assessment at European level.

The Hemraude study was conducted to describe the profile of patients with HA, disease management, and economic burden in a collective perspective. This retrospective study was conducted using the French administrative healthcare claims database SNIIRAM/SNDS. Male patients treated for hemophilia A with a long-term illness (ALD) status or invalidity were included in the study between January 1, 2016 and December 31, 2017. Patients were classified in six treatment groups: no treatment, on-demand FVIII, prophylactic FVIII, FVIII in immune tolerance induction (ITI) protocol, on-demand bypassing agents, and prophylactic bypassing agents. Patients treated with FVIII in ITI protocol and those treated with bypassing agents are deemed to have developed inhibitors. HA patients were compared to a control population without coagulation disorder and matched (ratio 1:3) on age and sex. A total of 4172 patients were included in the analysis, aged on average 35.2 years, 5.3% had HIV infection, and 8.8% had hepatitis B or C. In 2017, half of the patients received no treatment for HA, 46.7% were treated with FVIII (25% on demand, 20.6% with prophylaxis, and 1.1% ITI), 1.5% with bypassing agents. Patients treated with prophylactic treatments, either inhibitor or non-inhibitor, were less likely to be hospitalized for severe bleeding compared to patients receiving on-demand treatments. The average annual costs for HA management per patient were 72,209.60 €. The highest costs were observed in patients treated with FVIII in ITI protocol and those receiving prophylactic bypassing agents. Direct costs of HA treatments for HA may be very high especially in the small percentage of patients developing inhibitors or treated with ITI protocol.

Introduction Diabetes is a growing epidemic that imposes a substantial economic burden on healthcare systems. This study aimed to evaluate the cost of managing type 2 diabetes (T2D) with dipeptidyl peptidase 4 inhibitors (DPP4Is) using real-world data. Method This longitudinal study used data from the French EGB (Echantillon Généraliste des Bénéficiaires) database. The annual average direct healthcare cost of treating patients with T2D was calculated 3 years prior and 3 years after initiation of DPP4I therapy. Actual total ambulatory and hospital care expenditure for the 3 years after DPP4I initiation was compared to projected costs. The distribution of costs across all care modalities was assessed over the 6-year period. Results Ambulatory and hospital care expenditure data for 919 patients with T2D starting DPP4I therapy alone or in combination in 2013 were analyzed. A total of 526 patients (57.2%) were still being treated with DPP4I 3 years after DPP4I initiation. Regardless of the treatment regimen, the ambulatory and hospital care costs increased above projected costs in the first year following DPP4I initiation, and then declined during the second and third years to levels in line with or below projected values for patients using DPP4Is as an add-on therapy. The increase in total expenditure in the first year following DPP4I initiation and the subsequent decline in costs in the second and third years were both associated with general trends in consumption across all aspects of patient care. Conclusion Despite an initial increase in healthcare expenditure, concomitant with reevaluation of patient care, this study showed that initiation of DPP4Is as an add-on therapy in French patients with T2D was associated with care expenditure that was in line or below predicted values within the 3 years following treatment initiation. Additional studies are required to evaluate the economic impact of the long-term treatment benefits. Electronic Supplementary Material The online version of this article (10.1007/s13300-020-00760-x) contains supplementary material, which is available to authorized users.

The Hemraude study was conducted to describe the profile of patients with HA, disease management, and economic burden in a collective perspective.This retrospective study was conducted using the French administrative healthcare claims database SNIIRAM/SNDS. Male patients treated for hemophilia A with a long-term illness (ALD) status or invalidity were included in the study between January 1, 2016 and December 31, 2017. Patients were classified in six treatment groups: no treatment, on-demand FVIII, prophylactic FVIII, FVIII in immune tolerance induction (ITI) protocol, on-demand bypassing agents, and prophylactic bypassing agents. Patients treated with FVIII in ITI protocol and those treated with bypassing agents are deemed to have developed inhibitors. HA patients were compared to a control population without coagulation disorder and matched (ratio 1:3) on age and sex.A total of 4172 patients were included in the analysis, aged on average 35.2 years, 5.3% had HIV infection, and 8.8% had hepatitis B or C. In 2017, half of the patients received no treatment for HA, 46.7% were treated with FVIII (25% on demand, 20.6% with prophylaxis, and 1.1% ITI), 1.5% with bypassing agents. Patients treated with prophylactic treatments, either inhibitor or non-inhibitor, were less likely to be hospitalized for severe bleeding compared to patients receiving on-demand treatments. The average annual costs for HA management per patient were 72,209.60 €. The highest costs were observed in patients treated with FVIII in ITI protocol and those receiving prophylactic bypassing agents.Direct costs of HA treatments for HA may be very high especially in the small percentage of patients developing inhibitors or treated with ITI protocol.

Objective Our objectives were to describe the basal insulin treatment regimens most widely used in a real-world setting in France and to estimate the associated treatment costs in people with type 2 diabetes mellitus (T2DM). Methods A cross-sectional observational study was conducted (November 2017–February 2018) among adult patients with T2DM requiring basal insulin therapy for their own use in a representative sample of pharmacies. Costs were compared between patients treated with three recently marketed insulins (glargine 300 U/ml [Gla-300], biosimilar glargine 100 U/ml [Gla-100] and a fixed-ratio combination of insulin degludec and liraglutide) and those treated with three established basal or intermediate insulins: branded glargine 100 U/ml, insulin detemir and neutral protamine Hagedorn insulin [NPH]). Results Overall, 1933 patients were analysed. Gla-300 accounted for 59.9% of novel basal insulin prescriptions, and branded Gla-100 accounted for 67.9% of established insulin prescriptions. Recent insulins were more frequently associated with glucagon-like peptide-1 (GLP-1) analogues. Results confirmed a lower rate of severe hypoglycaemia with Gla-300 than with Gla-100. On average, weekly total costs of treatment with all basal insulins were not significantly different, except with detemir, where they were higher. Conclusion New basal insulins are expected to be integrated into clinical practice. This analysis shows that their use does not impact upon the management cost of insulin therapy in people with T2DM. Electronic supplementary material The online version of this article (10.1007/s41669-020-00237-4) contains supplementary material, which is available to authorized users.

Resume Il est probable que la prevalence du diabete traite pharmacologiquement va continuer a augmenter a un rythme modere dans les prochaines annees si une politique active de prevention de la maladie n’est pas mise en œuvre rapidement. De ce simple fait, les depenses consacrees a l’ensemble des patients diabetiques continueront de representer une part importante des depenses de sante. Pour limiter les consequences economiques de l’epidemiologie de la maladie et assurer le financement des innovations a venir, tout en ameliorant la qualite des soins delivres, il faudra sans doute trouver des gisements d’efficience dans notre systeme de sante en reformant en profondeur l’organisation des soins, la place des professionnels, et les modalites actuelles de financement des soins.

Resume En France a ce jour, il n’existe pas de definition claire de ce que recouvre la notion de population-cible d’un traitement dans la perspective de son remboursement. La pluralite des approches mises en œuvre pour estimer la taille de ces populations, selon les differents anti-hyperglycemiants, illustre le caractere peu scientifique de ces estimations. Il importe donc des lors de les considerer pour ce qu’elles sont, c’est-a-dire des elements servant d’appui dans la negociation d’un contrat entre les industriels du medicament et les payeurs publics.

Resume Les hypoglycemies constituent une des complications iatrogenes les plus problematiques des patients ayant un diabete. Leur frequence est variable selon le type de diabete et les classes therapeutiques utilisees. Les cas d’hypoglycemies les plus severes peuvent conduire a des hospitalisations, voire un passage en soins intensifs. Les couts pour la collectivite de ces evenements restent mal connus en France, plus specialement pour les patients diabetiques de type 2 (DT2). Il est possible de les approcher a travers une analyse des bases medico-administratives disponibles.

Resume L’evaluation des couts de traitements journaliers dans le diabete de type 2 (DT2) reste un exercice complexe en France. Les bases de donnees de l’Assurance maladie permettent d’approcher les couts en vie reelle, mais l’analyse comparee de differentes bitherapies d’antihyperglycemiants illustre les differences en termes de resultat relatif que l’on peut obtenir selon les approches utilisees. Dans le domaine du diabete, comme ailleurs, les choix therapeutiques devraient s’appuyer sur une evaluation comparative complete couts/resultats des strategies medicamenteuses.

Objectives Our objects was to estimate the direct healthcare costs of type 2 diabetes mellitus (T2DM) in France in 2013. Methods Data were drawn from a random sample of ≈600,000 patients registered in the French national health insurances database, which covers 90% of the French population. An algorithm was used to select patients with T2DM. Direct healthcare costs from a collective perspective were derived from the database and compared with those from a control group to estimate the cost of diabetes and related comorbidities. Overall direct costs were also compared according to the diabetes therapies used throughout the year 2013. Results Cost analysis was available for a sample of 25,987 patients with T2DM (mean age 67.5 ± standard deviation 12.5; 53.9% male) matched with a control group of 76,406 individuals without diabetes. Overall per patient per year medical expenditures were €6506 ± 10,106 in the T2DM group as compared with €3668 ± 6954 in the control group. The cost difference between the two groups was €2838 per patient per year, mainly due to hospitalizations, medication and nursing care costs. Total per capita annual costs were lowest for patients receiving metformin monotherapy (€4153 ± 6170) and highest for those receiving insulin (€12,890). However, apart from patients receiving insulin, costs did not differ markedly across the different oral treatment patterns. Conclusion Extrapolating these results to the whole T2DM population in France, total direct costs of diagnosed T2DM in 2013 was estimated at over €8.5 billion. This estimate highlights the substantial economic burden of this condition on society. Electronic supplementary material The online version of this article (doi:10.1007/s41669-017-0050-3) contains supplementary material, which is available to authorized users.

Objective France has included health economic assessment (HEA) as an official criterion for innovative drug pricing since 2013. Until now, no cost-effectiveness threshold (CET) has been officially proposed to qualify incremental cost-effectiveness ratios (ICERs). Although the French health authorities have publicly expressed the need for such reference values, previous initiatives to determine these have failed. The study aims to propose a locally adapted method for estimating a preference-based value for a quality-adjusted life-year (QALY) based on a rational approach to public policy choices in France. Methods We used the official French value of statistical life (VSL) of €3 million (USD 3.25 million), proposed in 2013 by the French General Commission on Strategy and Prediction. We first estimated the value of life-year (VoLY) by age category according to life expectancy and official discounts recommended for HEA in France. We then estimated a value of statistical QALY (VSQ) by weighting VoLYs with demographic data and French EQ-5D-3L tariffs. Results The estimated average VoLYs and VSQs were €120 185 (USD 130 000) and €147 093 (USD 159 022), respectively, assuming a discount rate of 2.5% and €166 205 (USD 179 681) and €201 398 (USD 217 728), respectively, assuming a discount rate of 4.5%. Conclusion Assuming that, as in other public domains, equity in access to healthcare across all disease areas and between all users is desirable, we propose an estimate of VSQ that is consistent with this goal. Our estimates of €147 093 (USD 179,681) to €201 398 (USD 217 728) should be perceived as breakeven costs for a QALY rather than a market access threshold. Such VSQs could be used as reference values for ICERs in HEA in France.

Resume Objectif Determiner la frequence du suivi plaquettaire et les risques hemorragiques associes a l’usage des anticoagulants injectables en vie reelle et estimer les couts associes. Methode Une analyse des donnees 2013 de l’echantillon generaliste des beneficiaires a ete realisee pour identifier les dosages plaquettaires effectues sur les periodes d’exposition aux anticoagulants injectables et les interruptions therapeutiques du fait d’une thrombopenie ou d’une transfusion. Ces evenements ont ete valorises et un differentiel de cout etabli. Resultats L’etude a porte sur 15 985 patients adultes representant 12 264 mois d’exposition aux anticoagulants injectables ; 2,8 % des sequences concernaient une heparine non fractionnee, 86,9 % une heparine de bas poids moleculaire et 13,1 % le fondaparinux. Les patients sous heparine non fractionnee etaient plus âges (77 vs 57 et 59 ans) avec des durees de traitement superieures (32,6 vs 25,1 et 21 jours). Le nombre mensuel moyen de dosages plaquettaires etait, apres ajustement, 1,36 fois inferieur chez les patients traites par fondaparinux par rapport aux heparines de bas poids moleculaire (p Conclusion Les patients sous fondaparinux effectuent significativement moins de dosages plaquettaires que les patients sous heparines de bas poids moleculaire sans risque hemorragique supplementaire. Cet aspect doit etre pris en compte dans l’evaluation des couts de ces traitements.

Introduction Une etude a ete conduite afin d’estimer le maintien des insulines basales (hors insuline degludec) chez les patients diabetiques de type 2 en vie reelle et de comparer la frequence des hypoglycemies severes hospitalisees en France sous ces traitements. Methodes L’etude a repose sur une analyse de la base Sniiram (donnees inter-regimes France entiere). Une cohorte retrospective de patients avec une premiere delivrance d’insuline basale (precedee par un an sans aucune insuline) ± antidiabetiques oraux/Agonistes du GLP-1 a ete constituee sur 2016/2017. Des analyses comparees du maintien des insulinotherapies basales disponibles ont ete conduites selon l’evenement de fin considere (arret de l’insuline etudiee, arret de toute insulinotherapie, intensification du traitement). Elles ont ete completees par une etude de la frequence des hypoglycemies hospitalisees et des passages aux urgences tous motifs sur la periode d’exposition. Resultats Toutes insulines basales confondues, 72 % des patients continuaient d’utiliser leur traitement apres 12 mois de traitement (75 % en schema basale seule). Ajuste sur les caracteristiques individuelles, l’odds-ratio pour les arrets de traitement est de 0,392 [0,371–0,414] en faveur de la glargine 300 U/mL(Gla-300) par rapport a la glargine 100 U/mL(Gla-100) tous schemas insuliniques a l’initiation et 0,378 [0,354–0,403] en schema basale seule. L’analyse des intensifications de traitement par insuline en schema basale seule chez les patients DT2 naifs d’insuline ne retrouve pas de difference entre les insulines. Les hypoglycemies hospitalisees etaient moins nombreuses sous Gla-300 (1,4 episodes/100 PA) contre 1,8 sous Gla-100 (OR = 0,665, [0,547–0,809]). Apres ajustement, la tendance observee n’atteint plus la significativite statistique. La frequence des passages aux urgences tous motifs est inferieure sous Gla-300 par rapport a la Gla-100 (test ajuste p Discussion/Conclusion En vie reelle, la glargine 300 U/mL a un meilleur maintien que la glargine 100 U/mL ou l’insuline detemir, peut-etre en partie en lien avec une moindre frequence de survenue des evenements hypoglycemiques necessitant une hospitalisation et des passages aux urgences.

International audience; To describe Self-Monitoring of Blood Glucose (SMBG) practices in France in patients with type 1 (T1DM) or type 2 (T2DM) diabetes, by estimating the proportion of patients performing SMBG at the recommended testing frequency and the proportion of patients complying with the current quality control guidelines on SMBG.

Resume Le financement de notre systeme d’Assurance maladie reste deficitaire. L’un des facteurs qui concourt a cette situation se situe au niveau de la progression des depenses consacrees a la prise en charge des maladies chroniques, telles que le diabete. Les remboursements aux personnes diabetiques pour l’ensemble de leur consommation croissent de +7,7 % par an selon la Caisse nationale de l’Assurance maladie des travailleurs salaries (Cnamts). Cette augmentation est liee, pour sa plus grande part, a l’augmentation du nombre de patients. Il conviendra certainement de completer les nombreuses actions qui ont ete mises en œuvre ces dernieres annees, en insistant sur la prevention primaire et une meilleure prise en charge des populations a risque. Il faudra sans doute egalement reformer en profondeur notre systeme de sante, tant en ville qu’a l’hopital.

To assess the frequency of platelet monitoring and bleeding risks associated with the use of injectable anticoagulants in a real life setting and to estimate the associated costs.An analysis of the 2013 data from a random sample of ≈600,000 patients registered in the French National Health Insurances reimbursement database was conducted to identify platelet counts performed during injectable anticoagulants exposure period and treatment interruptions due to heparin-induced thrombocytopenia or transfusion. Events were then valued to establish associated costs.Overall 15,985 adult patients representing a cumulated injectable anticoagulants exposure time of 12,264 months were selected. Treatment sequences involved unfractionated heparin (2.8%), low molecular weight heparin (86.9%), and fondaparinux (13.1%). Patients treated with unfractionated heparin were older (77 vs. 57 and 59 years) with longer treatment duration (32.6 vs. 25.1 and 21 days). After statistical adjustment, the average monthly number of platelet counts was 1.36-fold lower in patients treated with fondaparinux compared to low molecular weight heparin (P0.0001). No difference was found between low molecular weight heparin and fondaparinux regarding the incidence of bleeding with transfusion (P=0.76) or hospitalized thrombocytopenia (P=0.82). Extrapolated for the whole country, the estimated costs for biological monitoring were € 21.6 million for low molecular weight heparin and € 0.9 million for fondaparinux.Significantly fewer platelet counts were performed among patients treated with fondaparinux than among patients receiving low molecular weight heparin without additional bleeding risk. This finding should be taken into account when assessing the costs of such treatments.

Resume Propos Le purpura thrombopenique immunologique (PTI) de l’adulte est une maladie auto-immune evoluant le plus souvent sur un mode chronique dont le traitement, une fois passee la phase initiale, n’est pas parfaitement codifie. L’objectif de cette etude etait de decrire les modalites de traitement du PTI de l’adulte en France avant la mise a disposition des agonistes du recepteur a la thrombopoietine. Methodes Etude observationnelle retrospective conduite dans huit centres hospitaliers. Les patients inclus, âges d’au moins 18 ans et atteints d’un PTI chronique, ont ete vus sur une periode allant de janvier 2004 a mars 2006. La trajectoire therapeutique des patients a ete analysee en fonction de l’anciennete du diagnostic. Resultats Les donnees de 122 patients (73 % de femmes) d’âge moyen 52,6 ans ont ete colligees. Les patients dont le PTI avait ete diagnostique depuis moins de quatre ans (n = 71) avaient recu en moyenne 2,9 lignes therapeutiques. Le traitement de premiere ligne reposait essentiellement sur la corticotherapie plus ou moins associee aux immunoglobulines intraveineuses. Des la deuxieme ligne, 12 schemas therapeutiques differents ont ete identifies. Le rituximab et la splenectomie etaient les principales modalites therapeutiques en troisieme ligne, avec une tendance a un recours moins frequent et plus tardif de la splenectomie au fil du temps. Conclusion Cette etude revele la grande heterogeneite des pratiques dans la prise en charge du PTI chronique de l’adulte en France. L’impact des recommandations nationales emises apres cette analyse tout comme la place des agonistes du recepteur a la thrombopoietine devront etre precises.

Resume Introduction La prevalence de l’asthme en France est en augmentation et la proportion de cas mal controles demeure importante. Les consequences economiques de ce probleme de sante publique demeurent peu documentees. Une revue de la litterature a ete realisee en ce sens. Etat des connaissances Les etudes identifiees les plus anciennes ont cherche a differencier la consommation medicale liee a la prise en charge de l’asthme par niveau de severite. Seules les etudes plus recentes ont considere le niveau de controle de la maladie. Elles s’accordent a estimer que la consommation medicale directement associee a la prise en charge de l’asthme est dependante de la severite de la maladie et de son niveau de controle. Perspectives Les etudes ont integre les recommandations disponibles au moment de leur realisation pour definir la severite ou le controle, et leur comparabilite est donc delicate. De plus, l’evaluation economique qui porte sur des estimations de couts annuels est confrontee a la variabilite des niveaux de controle au cours du temps. Conclusions Si les donnees de la litterature concordent pour estimer qu’un meilleur controle de la maladie diminue significativement les couts, des etudes economiques s’appuyant sur les definitions recentes et utilisant une methodologie adequate seraient utiles.

Objectif Estimer la taille des populations (France entiere) pour lesquelles la vaccination grippale est recommandee et estimer la part de personnes vaccinees au sein de ces populations. Methode Une analyse des donnees de l’Echantillon generaliste des beneficiaires de l’Assurance maladie a ete realisee pour les saisons grippales 2012/2013, 2013/2014 et 2014/2015 (d’octobre a mars). Les differentes populations eligibles a la vaccination grippale ont ete identifiees a partir d’un ensemble d’algorithmes de selection sur la base des recommandations du calendrier vaccinal officiel. Au sein de ces populations, la proportion d’individus ayant ete rembourses pour un vaccin grippal en ambulatoire a ete estimee chaque saison. Les resultats bruts ont ete extrapoles a la population francaise en prenant en compte la distribution par âge et sexe des individus. Resultats La taille des populations ciblees par les recommandations a ete estimee a 17,6, 17,8 et 18,0 millions pour les saisons grippales 2012/2013, 2013/2014 et 2014/2015. Les personnes âgees de 65 ans et plus representaient respectivement 61,3 %, 62,3 % et 63,4 % de la population cible chaque saison. Concernant les taux de couverture vaccinale, ils ont ete evalues respectivement a 32,1 %, 31,9 % et 32,1 % pour l’ensemble de la population cible, a 44,2 %, 43,1 % et 42,7 % pour les personnes âgees de 65 ans et plus et a 12,9 %, 13,2 % et 13,7 % pour les personnes a risque âgees de moins de 65 ans. Conclusion Les taux de couverture vaccinale grippe sont tres inferieurs a l’objectif fixe par l’Organisation mondiale de la sante (OMS) (75 %) et sont particulierement bas chez les personnes a risque âgees de moins de 65 ans. Les resultats obtenus sont inferieurs aux taux de couverture vaccinale communiques par l’Assurance maladie (respectivement 50,1 %, 48,9 % et 46,1 %), taux calcules sur la base du ratio entre le nombre de bons de prise en charge utilises et envoyes.

Introduction L’echelle BDI/TDI (BDI : Baseline Dyspnea Index ; TDI : Transition Dyspnea Index) est un outil d’evaluation de la dyspnee. Objectifs Determiner, en France, les qualites metriques de cette echelle. Methode Une cohorte multicentrique de 103 patients suivis pour une BPCO peu severe a severe a ete interrogee parallelement a 2 reprises a 6 mois d’intervalle par un investigateur medical et un paramedical. Resultats La concordance inter-juges etait bonne pour tous les sous-scores de l’echelle BDI, moins bonne pour le score TDI. Le score BDI etait correle a l’ensemble des donnees spirometriques contrairement au score TDI correle uniquement avec l’evolution du VEMS. Les deux scores etaient correles avec les scores obtenus sur l’echelle modifiee du Medical Research Council, et sur le « St George Respiratory Questionnaire » ainsi qu’avec leur evolution. Le score TDI moyen proche de 0 chez les patients stables temoignait d’une bonne reproductibilite de l’echelle. La capacite de celle-ci a reperer un changement d’etat etait correcte par comparaison avec l’evaluation globale du medecin, moins avec celle du patient. Conclusion L’echelle BDI-TDI apparait comme un instrument interessant de mesure de la dyspnee chez les patients presentant une BPCO et, moins nettement, de son evolution dans le temps.

High-risk oncogenic human papillomavirus (HR-HPV) are strongly associated with squamous cell carcinoma and adenocarcinoma of the uterine cervix. Relatively detailed data on prevalence of HR-HPV infections by age in France are available in several cytologically normal women populations but none on incidence. These latter data may be obtained according to the relationship between prevalence and incidence due to the spontaneous viral clearance over time. The study has shown that HR-HPV infections incidence changes slightly according to the selected hypotheses for the viral clearance and that a peak is reached at about 12% for the women aged 22. A relatively high incidence is observed at older age classes with about 4% at 60 years old. These results are close to that observed in other countries even if the incidence peak appears slightly lower and happens later. Nevertheless, the model did not include possible viral reactivation or reinfection that could modify the incidence curve angle. The incidence of the HR-HPV infections is essential to define vaccination strategies and to determine the women ages at which the vaccine could be optimally administered.

Aim To describe the association between socio-economic position, health status and quality of diabetes care in people with Type 2 diabetes in France, where people may receive full healthcare coverage for chronic disease. Methods Data from a national cross-sectional survey performed in people pharmacologically treated for diabetes were used. They combined data from medical claims, hospital discharge, questionnaires for patients (n = 3894 with Type 2 diabetes) and their physicians (n = 2485). Socio-economic position was assessed using educational level (low, intermediate, high) and ability to make ends meet (financial difficulties vs. financially comfortable). Results People with diabetes reporting financial difficulties were more likely to be smokers (adjusted odds ratio 1.4; 95% CI 1.1–1.6) and obese (adjusted odds ratio 1.3; 95% CI 1.2–1.6) and to have poorer glycaemic control (HbA1c > 64 mmol/mol (8%); adjusted odds ratio 1.4; 95% CI 1.1–1.8), than those who were financially comfortable. They were more likely to have their diabetes diagnosed because of complications (adjusted odds ratio 1.6; 95% CI 1.3–2.0). They were also more likely to have coronary and podiatric complications (adjusted odds ratios 1.3; 95% CI 1.1–1.6 and 1.7; 95% CI 1.4–2.2, respectively). They benefited more often from full coverage (adjusted odds ratio 1.3; 95% CI 1.1–1.6), visited general practitioners more often (ratio of estimated marginal means 1.2; 95% CI 1.1–1.2) but specialists less often (adjusted odds ratio 0.7; 95% CI 0.6–0.8 for a visit to private ophthalmologist). They also felt less well informed about their condition. Conclusions Despite frequent access to full healthcare coverage, socio-economic position has an impact on the diagnosis of diabetes, health status and quality of diabetes care in France.

Objective The main objective of the SCOPE study was to estimate the total direct medical costs of patients with treated chronic obstructive pulmonary disease (COPD) in France according to severity stages. Methods Total medical resources consumption of a sample of COPD patients was collected over a 12-month period through a national physician survey (including both general practitioners and lung specialists). This survey was completed for 255 patients. Data were then extrapolated to all patients with diagnosed and treated COPD in France. Average total medical resources consumption of a COPD patient per year was €4366. Among this cost 41% was directly related to COPD follow-up, 25% to COPD-related complications (mainly exacerbations), and 34% to other diseases. More than one-third of the total direct COPD cost was related to hospitalizations and 31% to drug consumption. COPD-related costs increased markedly with severity based on FEV 1 (but data suggested the existence of a threshold effect). SCOPE data did not show any evidence of a significant relationship between direct medical cost and patient age, sex, addiction to tobacco, or duration of COPD. The total medical consumption of COPD patients in France was €3.5 billion and accounted for 3.5% of the total medical expenditures (prevalence of COPD was estimated 1.3% in the general population). Results The SCOPE study revealed the high level of medical resources consumption of patients with COPD. Conclusions The burden of COPD itself and its complications appeared to be of considerable magnitude in France especially for severe COPD.

Resume Objectifs Cette etude a ete realisee dans le but de determiner l’evolution du nombre de cas d’herpes genital et d’evaluer l’impact de differentes strategies de traitements en France. Methode Un modele d’histoire naturelle de l’infection genitale par le virus Herpes simplex est presente et applique a la population francaise. Le modele prend en compte les infections par le virus Herpes simplex type 1 (HSV-1) ou 2 (HSV-2), les premiers episodes, les recurrences, l’excretion virale et l’effet du traitement sur les individus infectes. Resultats Nous avons estime pour l’annee 2000 que 270 000 individus auraient souffert d’herpes genital en France. Le nombre annuel total cumule d’episodes de recurrence serait de 1,5 millions avec 23 millions de journees avec excretion virale. Nous avons estime que 70 p. 100 de ces dernieres concerneraient des sujets seropositifs sans signes cliniques. Le nombre attendu de deces neonatals attribuables resterait tres faible. Un traitement systematique des episodes cliniques pourrait reduire le nombre de jours avec lesions (– 27 p. 100) et etre egalement efficace sur l’excretion virale chez les malades symptomatiques (– 50 p. 100). Un traitement continu des malades les plus severes (≥ 6 recurrences par an) reduirait l’excretion virale (– 85 p. 100). Les traitements antiviraux pourraient avoir un impact majeur sur la qualite de vie des malades, mais ne devraient inflechir que modestement l’incidence des nouvelles infections. Discussion Le modele realise s’appuie sur l’ensemble des resultats partiels publies sur l’epidemiologie de l’herpes genital au niveau international. Toutefois, de nombreux aspects de cette maladie sont encore mal documentes et differentes hypotheses doivent etre retenues pour simuler l’histoire naturelle de l’herpes genital au niveau d’une population. L’absence de donnees francaises, notamment sur les profils de seroprevalence HSV-1 et HSV-2 par âge, constitue une source supplementaire d’incertitude. Les resultats obtenus presentent donc un caractere largement exploratoire. Ce type d’approche constitue toutefois le seul moyen possible pour integrer les multiples elements de connaissance de la maladie afin de predire l’impact de differentes strategies d’intervention de sante publique. Le modele presente doit donc etre concu comme un outil general qui pourra integrer dans l’avenir les nouvelles donnees qui seront produites.

Objectif Avec l’introduction et le retrait de certains medicaments hypoglycemiants, les traitements pharmacologiques du diabete de type 2 (DT2) ont change au cours des dernieres annees et les modalites d’utilisation des medicaments actuels ne sont pas connues. Cette etude a pour but de decrire les caracteristiques des patients DT2 et les schemas therapeutiques en 2013, en France. Methodes Les donnees sont issues de la base echantillon generaliste des beneficiaires (EGB), echantillon aleatoire de ≈600 000 patients enregistres dans la base de donnees de l’assurance maladie. Les patients DT2 ont ete identifies a partir de leurs consommations de medicaments hypoglycemiants, de l’existence d’un statut ALD pour diabete et d’un code diagnostique pour diabete au cours d’une hospitalisation. Les schemas therapeutiques des antidiabetiques ont ete estimes sur la base des prescriptions en T4-2013 et compares aux donnees de T4-2007. Resultats Globalement, 28 708 patients DT2 (prevalence estimee dans la base de donnees a 4,5 %, 8,8 % chez les patients âges de plus de 40 ans) ont ete identifies en 2013. L’âge moyen etait de 67,5 ans (SD 12,9), 54,1 % d’hommes. En T4, 41,2 % des patients DT2 etaient traites en monotherapie, 25,6 % en bitherapie, 13,7 % en multitherapie et 19,5 % par insuline associee ou non a un autre traitement hypoglycemiant. Comparativement aux donnees de 2007, une legere mais significative augmentation des combinaisons de traitements et de l’insuline a ete observee. L’utilisation de la metformine a augmente au cours du temps, en particulier en monotherapie (66 % en 2013 versus 50 % en 2007). Tous les thiazolidinediones et certains sulfamides ont ete remplaces par les iDPP4 et dans un moindre degre par les analogues GLP-1. Conclusion Les habitudes de prescriptions des traitements hypoglycemiants en France ont evolue au cours des dernieres annees, en parallele a l’introduction de nouvelles classes therapeutiques sur le marche, mais aussi probablement dans l’objectif d’un meilleur controle glycemique des patients. La connaissance de ces habitudes de prescriptions et d’utilisation en vie reelle demeure une dimension importante pour mieux comprendre le besoin therapeutique dans la prise en charge du DT2.

Objectif Avec l'introduction et le retrait de certains medicaments hypoglycemiants, les traitements pharmacologiques du diabete de type 2 (DT2) ont change au cours des dernieres annees et les modalites d'utilisation des medicaments actuels ne sont pas connues. Cette etude a pour but de decrire les caracteristiques des patients DT2 et les schemas therapeutiques en 2013, en France. Patients et Methodes Les donnees sont issues de la base EGB (Echantillon Generaliste des Beneficiaires), echantillon aleatoire de≈600 000 patients enregistres dans la base de donnees de l'assurance maladie. Les patients DT2 ont ete identifies a partir de leurs consommations de medicaments hypoglycemiants, de l'existence d'un statut ALD pour diabete et d'un code diagnostic pour diabete au cours d'une hospitalisation. Les schemas therapeutiques des antidiabetiques ont ete estimes sur la base des prescriptions en T4-2013 et compares aux donnees de T4-2007. Resultats Globalement, 28 708 patients DT2 (prevalence estimee dans la base de donnees a 4,5 %, 8,8 % chez les patients de plus de 40 ans) ont ete identifies en 2013. L'âge moyen etait de 67,5 ans (SD 12,9), 54,1 % d'hommes. En T4, 41,2 % des patients DT2 etaient traites en monotherapie, 25,6 % en bitherapie, 13,7 % en multi therapie et 19,5 % par insuline associee ou non a un autre traitement hypoglycemiant. Comparativement aux donnees de 2007, une legere mais significative augmentation des combinaisons de traitements et de l'insuline a ete observee. L'utilisation de la metformine a augmente au cours du temps, en particulier en monotherapie (66 % en 2013 versus 50 % en 2007). Tous les thiazolidinediones et certains sulfamides ont ete remplaces par les iDPP4 et dans un moindre degre par les analogues GLP-1. Conclusions Les habitudes de prescriptions des traitements hypoglycemiants en France ont evolue au cours des dernieres annees, en parallele a l'introduction de nouvelles classes therapeutiques sur le marche, mais aussi probablement dans l'objectif d'un meilleur controle glycemique des patients. La connaissance de ces habitudes de prescriptions et d'utilisation en vie reelle demeure une dimension importante pour mieux comprendre le besoin therapeutique dans la prise en charge du DT2.

Introduction Les resultats de l’essai NLST ont ouvert le debat sur l’opportunite d’un programme de depistage du cancer bronchopulmonaire (CBP) chez les personnes exposees a des cancerigenes respiratoires. L’objectif de ce travail est l’analyse cout–efficacite d’un programme de depistage du CBP dans une cohorte de sujets exposes a l’amiante. Methodes Les resultats de l’etude NLST (ajustes a l’âge) sont appliques a la population de la cohorte APEXS (6453 hommes exposes a l’amiante, ayant passe un scanner du thorax, suivi sans intervention specifique pendant 8 ans) pour determiner le nombre et le stade de CBP supplementaires qui seraient depiste ; la survie des CBP depistes a ete modelise en utilisant les donnees de la cohorte KBP 2010 ; les couts, limites aux couts directs, du point de vue de la Securite sociale, prennent en compte le cout du programme de depistage et de la prise en charge des CBP depistes. Resultats On estime 2,5 cas de CBP incident supplementaires pour 1000 sujets ayant les caracteristiques de la cohorte APEXS, depistes selon les donnees du NLST sur 2 ans ; un gain en annee de vie compris entre 6,2 a 9,7 et un ratio cout–efficacite variant de 32 039 a 40 359 euros par annee de vie gagnee. Conclusion Bien que superieur a ceux des programmes de depistage du cancer du sein ou du colon, ce ratio cout–efficacite se situe dans le champ de l’acceptable au regard des seuils habituels pour une intervention de sante.

Contexte et objectifs La base de donnees du Sniiram est un outil recemment mis a disposition des chercheurs en France. Meme si elle comporte peu de donnees medicales, cette base apporte des possibilites importantes de description des populations, des prises en charge et d’identification des parcours de soins. Elle constitue donc une opportunite de mieux identifier les parcours de fin de vie des enfants (parcours mal connus en France). L’equipe Ressources en soins palliatifs pediatriques d’Ile-de-France, PALIPED, a une mission d’integration de la demarche palliative dans la pratique de l’ensemble des professionnels de sante confrontes a la maladie grave, evolutive ou terminale en pediatrie. Pour cette equipe, la connaissance des parcours et des prises en charge est essentielle. Materiels et methodes L’analyse statistique de cette base (pour le seul Regime general, soit 85 % de la population) a ete realisee (apres obtention des accords IDS et Cnil). Elle a permis d’identifier les recours aux soins des enfants âges de 28 jours a 19 ans sur les mois precedents leur deces (a l’hopital ou a domicile), en Ile-de-France, en 2012 et 2013. Differents recodages des donnees medico-administratives ont ete necessaires. Resultats La population d’analyse est constituee de 1884 enfants. Les circonstances des deces ont ete identifiees dans 95,3 % des cas ( n = 1795) ; 36,1 % des deces non traumatiques ( n = 1709) relevaient de conditions chroniques complexes (CCC). Parmi ces CCC, les affections onco-immuno-hematologiques (37 %) et les atteintes neuromusculaires (21,7 %) etaient les plus frequentes ; 82,7 % des enfants sont decedes a l’hopital. Les enfants ont, en moyenne, passe un tiers de leur dernier trimestre de vie en hospitalisation avec des variations notables selon la pathologie sous-jacente. La duree moyenne du dernier sejour hospitalier a ete de 25,6 jours ; 41,5 % des enfants decedes de CCC sont passes au moins une fois par les urgences au cours des trois derniers mois de vie (13,8 % plusieurs fois). Conclusions Les bases de donnees de l’assurance maladie comportent des informations qui ont permis de decrire la population ciblee et de documenter les trajectoires de prise en charge des enfants susceptibles de beneficier de soins palliatifs de fin de vie, a une echelle populationnelle c’est-a-dire sur l’ensemble des enfants d’un territoire regional. L’analyse de ces bases represente une opportunite pour des equipes regionales de soins palliatifs pediatriques de mieux comprendre les prises en charge actuelles et de proposer des axes d’amelioration organisationnelle.

To estimate the prevalence of treated chronic obstructive pulmonary disease (COPD) and its associated costs by stage of severity.The study was conducted on the 2011 data of the french general beneficiary sample database (EGB). EGB is a 1/97th sample of the whole population of the beneficiaries of the main compulsory national health insurances. COPD cases and the level of severity of the disease have been identified using new algorithms established from the available parameters in EGB. Costs were estimated using a collective perspective.The minimal prevalence of treated COPD was estimated at 3.8% in patients of 40 years and older and 1.9% regardless of the age of individuals. This population was predominantly male (58.2%) with a mean age of 68.8 years (±12.7). A total of 6.2% of patients had a health-care utilization suggestive of a very severe stage of COPD and 8.1%, 13.8% and 71.9% suggestive of severe, moderate and mild stages respectively. Over one year, 28.8% of patients visited a specialist respiratory physician, 5.0% were hospitalized (≥24h) for COPD and 6.7% died. Patients experienced an average of 1.7 (±1.5) exacerbations per year and only 61.4% received specific pharmacological treatment for COPD during the year. The average yearly health-care cost of a patient with COPD was estimated at €9382, with €5342 directly related to COPD.This study based on medico-administrative databases confirms the high epidemiological and economic burden of COPD in France.

Objectives This paper presents an economic evaluation of a strategy of thromboprophylaxis in acutely ill medical patients with enoxaparin 40 mg vs. no intervention in the context of the French Health System. Methods The evaluation used a decision-analysis model to simulate the results of a hypothetical naturalistic, long-term study reflecting the usual care pattern for the patients. The short-term outcomes were derived from an international, double-blind, placebo-controlled randomized clinical study performed in 1102 patients older than 40 years. Treatment was scheduled to last 10 ± 4 days and primary outcome was venous thromboembolism events rates between days 1 and 14 assessed clinically or through systematic contrast venography. Results For an hypothetical cohort of 1000 hospitalized medical patients, the model suggested that the prophylaxis strategy would avoid between 1 and 10 deaths (median 4) and between 60 and 127 cases of venous thromboembolism events (median 94). By including or not the costs associated with long-term complications (post–phlebitis syndrome), the net extra cost per patient was estimated as a net saving or 35,857 Euros (€), respectively. The corresponding cost-effectiveness ratios in terms of cost per avoided death were a net saving or €8102 (median value), respectively. Conclusion Thromboprophylaxis with enoxaparin in hospitalized acutely ill patients over 40 years of age appears to be an efficient strategy using French cost data.

Aim: The aim of this study was to evaluate current practices for gastrointestinal bleeding prophylaxis in intensive care units (ICU) in France. Methods: A descriptive transversal one given day survey was performed based on a national sample of adult ICUs. This survey focused on usual practices of gastrointestinal bleeding prophylaxis, and also on the type of preventive treatment in patients on prolonged mechanical ventilation (over 48 hours). A one-way analysis of variance was conducted, followed by a multivariate analysis, the results of which showed the main factors involved. Results: One hundred and twenty-two ICUs participated in the survey, representing about 19% of the total amount of adult ICU beds. Of the 404 patients described, 268 (66.3%) received gastrointestinal bleeding prophylaxis on the day of the survey (omeprazole, 36.9%; ranitidine, 32.8%, or sucralfate, 30.2%). Preventive treatment was more common in medical or polyvalent units than in surgical ICUs (70.3% versus 55.2%; p < 0.01). The results did not show any association between the severity of the disease (estimated on an IGS II score basis) and the use of preventive treatment. Conversely, the latter was associated with the following factors: parenteral nutrition, shock, coagulopathy, history of gastrointestinal bleeding, and treatment with corticosteroids. Conclusion: It was found that most ICUs in France use prophylactic treatment for the prevention of gastrointestinal bleeding. This probably helps to reduce the incidence of such cases.

OBJECTIVE: To estimate the direct medical costs associated with obesity in France. DESIGN: Analysis of the French 1991–1992 National Household Survey database comprising a representative sample of 14,670 individuals aged 18 y and over. A subgroup of subjects with a body mass index (BMI)≥30 kg/m2 was compared with a control group of normal-weight individuals (BMI 18.5–25 kg/m2) matched on age, gender and education level. MEASUREMENTS: Self-reported weight and height used to calculate individual body mass index and health expenditures in a 3 month period, and morbidity as declared by respondents to the national household survey and verified on medical records. RESULTS: The direct cost attributable to obesity (BMI≥30 kg/m2) was estimated to be in the range 4.2–8.7 billion French Francs (FF) in 1992 value, that is between 0.7 and 1.5% of total health expenditures. CONCLUSION: These results were of the same order of magnitude as similar estimates obtained by a top-down approach for the same year and setting.

Resume Une evaluation medico-economique du baclofene (Lioresal ® ) intrathecal dans le traitement symptomatique de la spasticite chronique severe secondaire a des lesions medullaires (sclerose en plaque, traumatisme) a ete realisee selon une approche retrospective comparative monocentrique ou le sujet est son propre temoin ( n = 22). Les resultats de cette etude confirment l'efficacite importante du traitement sur la symptomatologie et l'etat fonctionnel des patients et sur une echelle de qualite de vie non specifique. Inversement, la mise en route d'un tel traitement se traduit par une augmentation de pres de 67 % des couts de prise en charge annuels moyens de ces patients pour atteindre environ 173 500 F/an. Un tel surcout peut sembler parfaitement acceptable au regard des benefices cliniques obtenus.

An outbreak of hepatitis A in a French day-care center was identified during a survey of risk factors for such events in a sample of 210 centers. In the period between 29 March and 9 July 1994, 17 cases were diagnosed in the center (anti-HAV IgM serum antibody) including 11 children aged 2-3 (attack rate = 55.5% of class), 2 staff members, 3 parents and 1 educator-parent (secondary attack rate = 27.6%). The source case was probably a classmate of Case 1's older brother, who was diagnosed earlier in the spring. Intensive hygiene measures and the organisational features of the clinic limited all transmission except by direct physical contact with infected children. Vaccination of staff was begun too late to be effective; gamma-globulin prophylaxis might have been administered but was not. This is the first documented outbreak of the disease in a French center.

Background Current asthma management guidelines are based on the level of asthma control. The impact of asthma control on health care resources and quality of life (QoL) is insufficiently studied. EUCOAST study was designed to describe costs and QoL in adult patients according to level of asthma control in France and Spain. Methods An observational cost of illness study was conducted simultaneously in both countries among patients age greater or equal to 18 with a diagnosis of asthma for at least 12 months. Patients were recruited prospectively by GPs in 2010 in four waves to avoid a seasonal bias. Health care resources utilization of the three months before the inclusion was collected through physician questionnaires. Asthma control was evaluated using 2009 GINA criteria over a 3-month period. QoL was assessed using EQ-5D-3L®. Results 2,671 patients (France: 1,154; Spain: 1,517) were enrolled. Asthma was controlled in 40.6% [95% CI: 37.7% - 43.4%] and 29.9% [95% CI: 27.6% - 32.3%] of French and Spanish patients respectively. For all types of costs, the percentage of patients using health care resources varied significantly according to the level of asthma control. The average cost (euros/3-months/patient) of controlled asthma was €85.4 (SD: 153.5) in France compared with €314.0 (SD: 2,160.4) for partially controlled asthma and €537.9 (SD: 2,355.7) for uncontrolled asthma (p® score was higher (p Conclusions In both countries, patients presenting with uncontrolled asthma had a significantly higher asthma costs and lower scores of Qol compared to the others.

A cost-effectiveness analysis of a vaccination program against Haemophilus influenzae type b (Hib) was conducted using French epidemiological data. The vaccine would be added as a fifth valence to the tetravalent vaccines (DTCP) widely used in France. The permanent sequelae of the Hib invasive diseases which might be avoided by vaccination were weighted to determine Quality Adjusted Life Years gained. In a stable French population of 3,746,000 children aged < 5 years old (1990), and for a followup period of ten years, the cost-effectiveness ratio of such a program for the French national health insurance system would equal 54,084 FF per year of life added or 34,050 FF per QALY. The net cost of the program during that period would be 1.02 billion FF for the French national health insurance system and 920 million FF for patients' families. Comparison of these projections with available information supports, a posteriori, the decision of the French government to authorize the licensing of the pentavalent vaccine.

Objectif Estimer les couts directs de prise en charge du diabete de type 2 (DT2) en France, en 2013, en distinguant la consommation totale des ressources utilisees pour les patients DT2 des couts directement attribuables au diabete et ses complications. Methodes Les donnees sont issues de la base EGB (echantillon generaliste des beneficiaires), echantillon aleatoire de ≈600 000 patients enregistres dans la base de donnees de l’Assurance maladie. Les patients DT2 ont ete identifies a partir de leurs consommations de medicaments hypoglycemiants, de l’existence d’un statut ALD pour diabete et/ou d’un code diagnostique diabete au cours d’une hospitalisation. Les couts directs ont ete estimes selon une perspective collective. Le fardeau du DT2 a ete evalue en comparant les couts des depenses de sante observees chez les patients DT2 versus une population temoin appariee sur l’âge, le sexe et la region de residence. Resultats L’analyse a ete realisee dans l’ensemble de la population DT2, soit 25 987 patients (âge moyen 67,5 ans [SD 12,5], 53,9 % d’hommes) appariee a un groupe temoin de 76 406 sujets non diabetiques et presents dans la base en 2013. Les depenses annuelles totales de sante par patient s’elevaient a 6506€ (ET : 10 106) dans la population DT2 versus 3668€ (ET : 6954) pour les temoins ( × 1,8). Parmi les patients diabetiques, les postes de depenses les plus eleves etaient les hospitalisations (33,2 % des depenses totales), les depenses de pharmacie ou produits derives en ville (23,8 %), auxiliaires medicaux (13,5 %), consultations ou actes medicaux en ville (11,5 %). Peu de differences de couts etaient observees parmi les patients traites par monotherapie, bitherapie ou multitherapie (respectivement : 4,779, 4,555, 4,75€ par patient). En revanche, les depenses de sante etaient beaucoup plus elevees chez les patients traites par insuline versus ceux sans insuline (12,88€ versus 4,84€). Conclusion En extrapolant a l’ensemble de la population de DT2 en France, les couts directs totaux du DT2 en 2013 ont ete estimes a plus de 9 milliards d’euros en France. Cette estimation met en evidence le fardeau economique considerable que cette pathologie impose a la societe.